Comparative Efficacy of Organizational Skills Training (OST) and Mindfulness-Based Intervention (MBI)

NCT07089745 | Recruiting

• 1 other identifier: Pro00117601
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized control trial comparing Organizational Skills Training (OST) and Mindfulness-Based Intervention (MBI) among adolescents with a pre-existing ADHD diagnosis presenting to the Duke ADHD Program. Both treatments are eight 90 minute sessions. The research component will involve a pre-treatment assessment and post-treatment assessment. Both assessments will involve adolescents and one caregiver to complete questionnaires over REDCap. Rating scales will include ADHD symptom severity (Conners 3: self and parent report), functional impairment (IRS: self and parent report), executive functioning (BRIEF-2: parent report), emotion dysregulation (DERS: self and parent report), trait mindfulness (FFMQ: self report), organizational skills (BRIEF-2: parent report), treatment satisfaction (self report and parent report) and credibility (self report and parent report). Post-treatment assessments for feasibility will include attendance (measured over the course of treatment) and homework completion rates on a scale of 1 to 5 in which 5 indicates higher homework completion. We will also assess acceptability via individual items on a Likert scale (self report): overall satisfaction, how much was learned about ADHD, usefulness of information learned, content relevance to individual experience, comprehension of strategies, confidence about using strategies, likelihood of using strategies, helpfulness to share with the group, benefits from hearing from other group members, willingness to recommend the same treatment to others, and whether or not treatment was beneficial.

Conditions

ADHD; ADHD - Attention Deficit Disorder With Hyperactivity

Keywords

adhd; attention deficit hyperactivity disorder

Outcome Measures

Primary Outcomes (6)

• ADHD symptoms

  Measured using the Conners 3 self and parent reports from the pre- and post- treatment questionnaires. Participants will rate several statements using a scale ranging from 0 to 3 (from Not True at All to Very Much True). Higher scores indicate more behavioral, emotional, or ADHD-related concerns.

  From enrollment to the end of treatment at 8 weeks

• Functional Impairment

  Measured using the Impairment Rating Scale \[IRS\]: self and parent reports from the pre-and post-treatment questionnaires. Each item rated 0-6; total or mean scores vary by scoring method, with higher scores indicating greater functional impairment.

  From enrollment to the end of treatment at 8 weeks.

• Executive Functioning

  Measured using Behavior Rating Inventory of Executive Functioning \[BRIEF-2\]: parent report from pre-and post-treatment questionnaires. Participants will rate several behaviors on a scale of 1-3 depending how often that behavior occurs. Higher scores indicate higher executive functioning difficulties.

  From enrollment to the end of treatment at 8 weeks.

• Emotion Dysregulation

  Measured using Difficulties in Emotion Regulation Scale \[DERS\]: self and parent reports from pre-and post-treatment questionnaires. Each item on the DERS is rated using a 5-point Likert scale, with higher scores indicating greater difficulties with emotional regulation.

  From enrollment to the end of treatment at 8 weeks.

• Trait Mindfulness

  Measured using the Five Facet Mindfulness Questionnaire \[FFMQ\]: self report given during the pre-and post-treatment questionnaires. Each item on the FFMQ is rated using a 5-point Likert scale, with a higher total score indicating greater mindfulness.

  From enrollment to the end of treatment at 8 weeks.

• Organizational Skills

  Measured using the Behavior Rating Inventory of Executive Functioning (BRIEF-2): parent report given during the pre- and post- treatment questionnaires. Participants will rate several behaviors on a scale of 1-3 depending how often that behavior occurs. Higher scores indicate higher executive functioning difficulties.

  From enrollment to the end of treatment at 8 weeks.

Study Arms (2)

Organizational Skills Training (OST)

EXPERIMENTAL

Adolescents with an ADHD diagnosis (confirmed via Duke's electronic health record or an external documentation of a diagnosis) seeking treatment at the Duke ADHD Program will be recruited. They will be randomized 1:1 to OST or MBI, which are both treatments that are offered as standard clinical care, billable treatments at the Duke ADHD Program. Adolescents and their caregivers will complete rating scales at pre-treatment and post-treatment remotely via Research Electronic Data Capture. Both treatments are eight 90 minute sessions and are offered as billable services by the Duke ADHD Program as a standard of care.

Behavioral: Organizational Skills Training

Mindfulness-Based Intervention (MBI)

EXPERIMENTAL

Adolescents with an ADHD diagnosis (confirmed via Duke's electronic health record or an external documentation of a diagnosis) seeking treatment at the Duke ADHD Program will be recruited. They will be randomized 1:1 to OST or MBI, which are both treatments that are offered as standard clinical care, billable treatments at the Duke ADHD Program. Adolescents and their caregivers will complete rating scales at pre-treatment and post-treatment remotely via Research Electronic Data Capture. Both treatments are eight 90 minute sessions and are offered as billable services by the Duke ADHD Program as a standard of care.

Behavioral: Mindfulness-Based Intervention

Interventions

Mindfulness-Based Intervention BEHAVIORAL

MBI is a treatment offered as standard clinical care, billable treatments at the Duke ADHD Program. There are eight 90 minute long sessions.

Also known as: MBI

Mindfulness-Based Intervention (MBI)

Organizational Skills Training BEHAVIORAL

OST is a treatment offered as standard clinical care, billable treatments at the Duke ADHD Program. There are eight 90 minute long sessions.

Also known as: OST

Organizational Skills Training (OST)

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Adolescent between the ages of 13-17 years
• Pre-existing diagnosis of ADHD in medical record
• Seeking treatment at the Duke ADHD Program

You may not qualify if:

• Psychiatric comorbidity that interferes with treating ADHD as the presenting concern per the study team.
• Other concerns besides ADHD that would interfere with study participation according to the study team.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27705, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• John Mitchell, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John Mitchell, PhD

CONTACT

919-681-0012; john.mitchell@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: July 28, 2025
• Study Start: September 18, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)